K042287 is an FDA 510(k) clearance for the UNIPLAIN & UNICHROM, a Suture, Absorbable, Natural (Class II — Special Controls, product code GAL), submitted by United Medical Industries Co. , Ltd. (Riyadh, Central Province, SA). The FDA issued a Cleared decision on September 7, 2005, 379 days after receiving the submission on August 24, 2004. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4830.
| 510(k) Number | K042287 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 24, 2004 |
| Decision Date | September 07, 2005 |
| Days to Decision | 379 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GAL — Suture, Absorbable, Natural |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4830 |